Corporate Banner
Satellite Banner
Technology
Networks
Scientific Communities
 
Become a Member | Sign in
Home>Events>This Event
  Events - October 2012


QbD Lifecycle Management for Analytical Methods

25 Oct 2012 - 26 Oct 2012 - London, UK



Bookmark and Share


A QbD and lifecycle management approach to analytical method development and qualification will result in a better understanding and fewer failures of analytical methods due to more robust methods which produce consistent, reliable, quality data throughout the lifecycle. This, in turn, will lead to less method transfer failures, OOS results and method “incidents” when used in the routine environment. As the industry is moving towards applying Quality by Design (QbD) to process development - Is this also the way forward to improve and standardise our approach to method qualification?

This two day training course presents a brief overview of method validation according to ICHQ2 (R1) and discusses the limitations of this approach in terms of its contribution to failure of methods with regards to method transfer and generation of OOS results later in the method lifecycle. It then introduces the concept of QbD in relation to analytical methods and focuses on the application of a three stage approach of QbD and lifecycle management. Finally a comparison of the current approach (ICHQ2) and the QbD approach is presented.

The course focuses on HPLC methods; therefore experience in developing, validating and transferring analytical HPLC methods would be an advantage to participants. The material is presented by means of slides, handouts and participation of the attendees through discussion, case studies and hands on group exercises.

Course objectives
This course is designed to provide training in how to apply Quality by Design and lifecycle
management to the development and qualification of analytical methods. It aims to highlight the limitations of the current approach to method validation (ICHQ2) and the benefits to using the QbD approach.
Although the QbD and Lifecycle management approach is not yet officially recognised for analytical methods, the course is based on the approach used for manufacturing processes and products as described in ICH Q8, Q9 and Q10. The course emphasises practical issues such as:
• Comparison of the traditional approach and QbD/lifecycle approach to analytical methods
• Applying the QbD and lifecycle approach to development and qualification of analytical methods
• Exploring and controlling variables of analytical methods
This course will deliver the tools to enable you to:
• Consider a QbD and lifecycle management approach to analytical methods
• Define an Analytical Target Profile
• Recognise the importance of understanding method variables of individual methods
• Develop more robust analytical methods
Who should attend
This 2 day course is valuable for Managers, Supervisors, Laboratory Analysts and Associates
involved in the development, validation, transfer or review of analytical methods in the Pharmaceutical and related industries with daily responsibilities in the following areas:
• Quality Assurance
• Quality Control Laboratory
• Regulatory Affairs
• Contract Laboratory
• Analytical Development Laboratory
• Training

Further information
Scientific News
Platelets are the Pathfinders for Leukocyte Extravasation During Inflammation
Findings from the study could help in the prevention and treatment of inflammatory pathologies.
ASMS 2016: Targeting Mass Spectrometry Tools for the Masses
The expanding application range of MS in life sciences, food, energy, and health sciences research was highlighted at this year's ASMS meeting in San Antonio, Texas.
Benchtop Automation Trends
Gain a better understanding of current interest in and future deployment of benchtop automated systems.
Some Women With PCOS May Have Adrenal Disorder
Researchers at NIH have found that a subgroup of women with PCOS, a leading cause of infertility, may produce excess adrenal hormones.
Alzheimer's Genetics Point To New Research Direction
A University of Adelaide analysis of genetic mutations which cause early-onset Alzheimer’s disease suggests a new focus for research into the causes of the disease.
Penn State, TB Alliance, and GSK Partner To Discover New Treatments For TB
A new collaboration between TB Alliance, GSK, and scientists in the Eberly College of Science seeks to find new small molecules that can be used to create antibiotics in the fight against tuberculosis (TB).
Manufactured Stem Cells To Advance Clinical Research
Clinical-grade cell line will enable development of new therapies and accelerate early-stage clinical research.
Faster Detection of Pathogens in the Lungs
Thanks to new molecular-based methods, mycobacterial pathogens that cause pulmonary infections or tuberculosis can now be detected much more quickly.
Contagious Cancers Are Spreading in Shellfish
Direct transmission of cancer among some marine animals may be more common than once thought, suggests a new study published in Nature by researchers at Columbia University Medical Center (CUMC).
Contagious Cancers Are Spreading in Shellfish
Direct transmission of cancer among some marine animals may be more common than once thought, suggests a new study published in Nature by researchers at Columbia University Medical Center (CUMC).
Scroll Up
Scroll Down
Skyscraper Banner

Skyscraper Banner
Go to LabTube
Go to eposters
 
Access to the latest scientific news
Exclusive articles
Upload and share your posters on ePosters
Latest presentations and webinars
View a library of 1,800+ scientific and medical posters
3,200+ scientific and medical posters
A library of 2,500+ scientific videos on LabTube
4,700+ scientific videos
Close
Premium CrownJOIN TECHNOLOGY NETWORKS PREMIUM FOR FREE!